Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
NCT00507338
Protocol/serial number
ARC1779-003
Study information
Scientific title
A phase 2 study of an aptameric von Willebrand Factor antagonist, ARC1779, in patients with acute myocardial infarction undergoing percutaneous coronary intervention
Acronym
vITAL-1
Study hypothesis
Adjunctive anti-thrombotic therapy for PCI of Acute Myocardial Infarction (AMI) may be improved by incorporation of a novel anti-platelet therapeutic principle, von Willebrand Factor antagonism. ARC1779 is a therapeutic oligonucleotide ("aptamer") which blocks the binding of the A1 domain of vWF to the platelet GP1b receptor, and thereby modulates platelet adhesion, activation, and aggregation under the high shear conditions of coronary arterial stenosis and plaque rupture. This study is intended to provide dose-ranging and clinical proof of concept for ARC1779 in a primary PCI population.
Ethics approval(s)
Ethics Committee of the Medical University of Vienna and the General Hospital of the City of Vienna. Date of approval: 27 November 2007
Study design
Randomized, double-blind (subject, caregiver, investigator, outcomes assessor), active control, parallel assignment, multi-center, safety/efficacy study.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Condition
Acute myocardial infarction
Intervention
Please note that as of 14/05/2008 this trial was terminated.
Procedure: Primary PCI
Study Drugs: Active control - Abciximab (ReoPro®) labeled regimen for primary PCI. Investigational agent - ARC1779 Injection 0.1 mg/kg, 0.3 mg/kg, or 1.0 mg
Duration: Bolus + 12 hr infusion
Frequency: 1 x treatment
Mode of Administration: Intravenous
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
aptameric von Willebrand Factor antagonist (ARC1779)
Primary outcome measure
Adequacy of reperfusion (Time frame: 48 hours post-PCI)
Secondary outcome measures
Bleeding (Time frame: PCI to hospital discharge)
Overall study start date
01/10/2007
Overall study end date
31/10/2008
Reason abandoned (if study stopped)
Trial terminated due to the mode of administration of drug being unfeasible for this proposed indication. Please keep reason for termination confidential.
Eligibility
Participant inclusion criteria
1. Troponin-positive Non-ST-segment Elevation Myocardial Infarction (NSTEMI), with diagnostic symptoms and/or electrocardiogram (ECG) abnormalities present within the preceding 24 hours, and a planned "early invasive" management strategy
2. ST-Segment Elevation Myocardial Infarction (STEMI), with planned primary PCI
Participant type(s)
Patient
Age group
Not Specified
Sex
Both
Target number of participants
300
Participant exclusion criteria
1. History of bleeding diathesis or evidence of active abnormal bleeding within the previous 30 days
2. Received treatment with fibrinolytic or GPIIb/IIIa antagonist drugs within the preceding 72 hours
3. Received anticoagulant therapy with a low molecular weight heparin within the preceding 8 hours
4. Severe hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg) not adequately controlled on antihypertensive therapy
5. Major surgery or trauma within the preceding 6 weeks
6. History of stroke within 30 days or any history of hemorrhagic stroke
7. End-Stage Renal Disease (ESRD) with dependency on renal dialysis
Recruitment start date
01/10/2007
Recruitment end date
31/10/2008
Locations
Countries of recruitment
Austria, Canada, Germany, Israel, Poland, Russian Federation, United States of America
Study participating centre
350 Longwood Avenue
Boston
02115
United States of America
Sponsor information
Organisation
Archemix Corp (USA)
Sponsor details
300 3rd Street
Cambridge
02142
United States of America
+1 617 621 7700
jgilbert@archemix.com
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Archemix Corp (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|